Bio-Thera Solutions, Ltd. announced that the United States Food and Drug Administration has approved Avzivi (bevacizumab-tnjn), a biosimilar referencing Avastin. Avzivi is Bio-Thera's second USFDA approved product and is the second biosimilar researched, developed, and manufactured by a Chinese pharmaceutical company to receive FDA approval in the United States. The FDA approval of Avzivi was based on a comprehensive analytical, non-clinical and clinical data package submitted by Bio-Thera to the FDA.

Extensive analytical characterization between BAT1706 and US and EU Avastin was conducted on structural, physicochemical, and biological properties to support biosimilarity of BAT1706. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including three approved products: QLETLI®? in China, and TOFIDENCE/BAT1806 and Avzivi /Pobevcy in the US and China.

In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as ADCs.